Quality Assurance Specialist
Listed on 2026-07-01
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Quality Assurance - QA/QC
Production QC/QA, Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager
Quality Assurance Specialist
The Specialist, Quality Operations QA is an experienced senior level position within Quality Operations. This position will provide on-site operational support from Monday – Friday during the hours of 8 AM – 4 PM at Alnylam's Norton Manufacturing Facility. The Specialist role is capable of supporting all aspects of cGMP production.
Key Responsibilities:
- QA review and approval of deviations, CAPAs, change controls, PM Plans, Work Orders
- QA review and approval for master batch records (MBRs), SOPs, specifications, raw materials, executed batch records for all unit operations
- Performing Area Clearance, Change over operations and OTF support for manufacturing operations
- Independently providing forward processing decisions during manufacturing discrepancies
- Lead and own disposition activities for the release of API, DS and DSI
- SOP generation and ownership for Quality related functions
- Ensure adherence to Quality systems for internal manufacturing facilities
- Quality oversight of New Product Introductions / Product Re-introductions
- Lead and drive site inspection readiness and provide QA support in partner audits and regulatory inspections
- Serves as primary QA contact during Major / Critical manufacturing events
- Lead complex cross-functional investigations
Qualifications:
- A minimum of Bachelor's degree in sciences or engineering
- A minimum of 5-8 years of QA operations experience in a GMP manufacturing facility
- Experience with Quality oversight in GMP Operations from Early Stage to Commercial
- Excellent understanding of FDA, EMA regulations and ICH guidelines
- Excellent organizational, communication, and interpersonal skills
- Experience with electronic Quality Management Systems
U.S. Pay Range $88,700.00 - $
The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).
Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k) with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
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